Market Regulation - Therapeutic Goods Administration

Market Regulation - Therapeutic Goods Administration

Market regulation aims to ensure that new therapeutic goods are safe, perform as intended and are produced using appropriate standards before market approval for use in Australia is granted. Market regulation also ensures that goods that are found to be unsafe are removed from the market. This function is established under the Therapeutic Goods Act 1989 and is currently the responsibility of the Therapeutic Goods Administration (TGA), which is part of the Australian Government’s health portfolio. Approved therapeutic goods are entered on the Australian Register of Therapeutic Goods (ARTG). Where a therapeutic good is considered for reimbursement, the TGA approval process must be completed before the reimbursement decision is finalised.

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 came into effect in February 1991 and provides a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices.

Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is Australia’s independent national regulator of therapeutic goods and is responsible for ensuring that only safe and effective health technologies are marketed for supply in Australia. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. The TGA also aims to ensure that the Australian community has timely access to therapeutic advances.

The TGA regulates therapeutic goods through:

pre-market assessment;

post-market monitoring and enforcement of compliance with standards; and

licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts.

In undertaking its regulatory role, the TGA adopts a risk management approach by:

identifying, assessing and evaluating the risks posed by therapeutic goods;

applying any measures necessary for treating the risks posed; and

monitoring and reviewing risks over time.

Australian Register of Therapeutic Goods

The Australian Register of Therapeutic Goods (ARTG) was established under the Therapeutic Goods Act 1989. The Act requires that medical products to be imported into, supplied in, or exported from Australia be entered on the ARTG. For a product to be entered on the ARTG, a sponsoring company must make an application which usually consists of a form accompanied by data to support the quality, safety and efficacy of the product for its intended use.

The Therapeutic Goods Act 1989, Regulations and Orders set out the requirements for inclusion of therapeutic goods on the ARTG, including advertising, labelling, product appearance and appeal guidelines. The ARTG is updated in real time.

Listing, registration or inclusion on the ARTG is generally a requirement for any health technology to enable it to be listed for reimbursement under an Australian Government funding program.

Committees

The TGA has seven statutory expert committees it may call upon to obtain independent advice on scientific and technical matters.

If your enquiry relates to a specific function of the TGA, a range of other information lines for specific issues are listed on the TGA website, which may be helpful in dealing with your particular enquiry.